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FDA 510(k)

FLXfit™

K-Number: K171519 · 2017-09-15

ApplicantExpanding Orthopedics, Inc.
Decision Date2017-09-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLXfit™ is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K171519. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLXfit™?

FLXfit™ is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Expanding Orthopedics, Inc.. The 510(k) number is K171519.

When did FLXfit™ receive FDA 510(k) clearance?

FLXfit™ received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171519.

Who is the listed applicant for FLXfit™?

The FDA 510(k) record lists Expanding Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLXfit™?

The FDA product code for FLXfit™ is MAX.

Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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